Nebulized Lidocaine and Intranasal Midazolam for NGT Insertion in Children
Procedural Anxiety, Procedural Pain
About this trial
This is an interventional treatment trial for Procedural Anxiety
Eligibility Criteria
Inclusion Criteria:
1 Previously healthy children 6 months to 5 years old presenting with AGE and some dehydration who were planned to have a nasogastric tube inserted as part of their ED treatment.
Exclusion Criteria:
- Indication for an urgent insertion of a nasogastric tube.
- Congenital anomalies of nose, nasopharynx, oropharynx, or oral cavity.
- .Patients allergic to midazolam or lidocaine.
- .Congenital Heart disease or arrhythmia.
- .Known hepatic or renal impairment
- .Developmentally abnormal children
- .Patients with seizure disorder
- .Pre-existing abnormal neurological conditions
- .Child is taking medications known to interact with lidocaine and/or midazolam (antiarrhythmic drugs, suxamethonium, phenytoin, antidepressants, propranolol, citicoline).
- .Known case of severe gastroesophageal reflux disease or aspiration pneumonia.
Sites / Locations
- Pediatric Emergency Center, Hamad Medical CorporationRecruiting
- Sidra Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Arm 1
Arm 2
Arm 3
Nebulized 2% lidocaine hydrochloride 4 mg/kg to be delivered via nebulization (up to a maximum of 15 ml) and given over ½ hr. Intranasal midazolam 0.5 mg/kg delivered via intranasal atomization (up to a maximum of 10 mg).
Intranasal midazolam 0.5 mg/kg to be delivered via intranasal atomization (up to a maximum of 10 mg). Nebulized placebo (Normal saline) in a volume comparable to 2% lidocaine at 4 mg/kg (up to a maximum of 15 ml) and given over ½ hr.
Intranasal placebo (normal saline) in a volume comparable to midazolam 0.5 ml/kg to be delivered via intranasal atomization Nebulized placebo (Normal saline) in a volume comparable to 2% lidocaine at 4 mg/kg (up to a maximum of 15 ml) and given over ½ hr.